Covering the whole development process for the global biotechnology industry

Bioprocessing begins upstream, most often with culturing of animal or microbial cells in a range of vessel types (such as bags or stirred tanks) using different controlled feeding, aerating, and process strategies.

Beginning with harvest of material from a bioreactor, downstream processing removes or reduces contaminants to acceptable levels through several steps that typically include centrifugation, filtration, and/or chromatographic technologies.

Drug products combine active pharmaceutical ingredients with excipients in a final formulation for delivery to patients in liquid or lyophilized (freeze-dried) packaged forms — with the latter requiring reconstitution in the clinical setting.

Many technologies are used to characterize biological products, manufacturing processes, and raw materials. The number of options and applications is growing every day — with quality by design (QbD) giving impetus to this expansion.

Even as it matures, the biopharmaceutical industry is still a highly entrepreneurial one. Partnerships of many kinds — from outsourcing to licensing agreements to consultancies — help companies navigate this increasingly global business environment.

Emergent adds its first European biomanufacturing facility through the acquisition of vaccine maker PaxVax. Meanwhile in Baltimore, the firm has announced a $50 million fill/finish expansion.

The US$270 million (€236 million) adds two vaccines approved by the US against cholera and typhoid fever to Emergent BioSolutions’ portfolio, along with several candidates including an Adenovirus 4/7 vaccine being developed for military personnel under contract with the US Department of Defense (DoD).

The acquisition also brings Emergent its first biomanufacturing facility outside the US, in Bern, Switzerland, and the latest boost to its contract development and manufacturing organization (CDMO) business.

“The addition of the Bern facility achieves that European presence, which we also believe will create new prospects to grow our business and non-dilutive funding options through more direct exchanges with European partners and beyond,” Sean Kirk, Emergent’ SVP of manufacturing operations and head of the CDMO business told BioProcess Insider.

“Additionally, the Bern facility gives us ample space and much opportunity to consider not only in the area of expanded Ex-US CDMO business development, but also European supply chain/ distribution.”

The former Johnson & Johnson facility itself is in good regulatory and operational standing, Kirk added, and includes an array of capabilities including fermentation with bioreactors at a scale of up to 3000 L and other manufacturing capability currently and potentially supporting viral/ non-viral manufacturing such as prokaryotic, recombinant, eukaryotic, and viral platform.

The plant also has lyophilization, encapsulation, and warehouse/distribution capabilities, along with a staff of around 80.

“We see the skills and physical capabilities of the PaxVax personnel and the Bern facility to be not only complementary, but also additive to Emergent’s portfolio of plants,” said Kirk. “They bring skills and technologies that we did not readily have available, and we will look to leverage those inherent strengths to drive value within our own product portfolio as well as for our external clients.”

Baltimore: $50m fill/finish expansion

In related news, Emergent will expand a plant in Baltimore to feed demand for biologics fill/finish services.

For the second quarter 2018, Emergent BioSolutions reported revenues of US$202 million (€175 million), up 118% on the same period last year.

The majority came from sales of its own products, especially anthrax vaccine BioThrax and smallpox vaccine ACAM2000, but the firm also saw an increase of 46% in its contract development and manufacturing organization (CDMO) business to $24 million.

And to continue this momentum, the firm has announced a $50 million expansion at its Camden, Baltimore fill/finish facility over the next three years.

“This effort will enable continued success in growth in our CDMO business unit through the addition of capacity and capabilities aligned with the growing needs of our current and new commercial customers,” COO Bob Kramer told investors on a call last week.

Anthrax MAb

He added the expansion will also add new capabilities to support manufacture of “a growing portfolio of our own internal products,” including the monoclonal antibody (Mab) raxibacumab acquired from GlaxoSmithKline in July 2017.

The deal saw Emergent assume responsibility for supplying the US FDA approved anthrax treatment to the Biomedical Advanced Research and Development Authority (BARDA). GSK currently makes the MAb on behalf of Emergent, but all manufacturing activity is set to be transferred inhouse by 2020.

The drug substance manufacturing will be undertaken at Emergent’s Bayview facility in Baltimore, while the fill/finish will take place at the expanded Camden plant. During the quarter, Emergent completed an FDA type C meeting, an important milestone in supporting the production transfer.

Rich Lindahl, Emergent’s CFO, explained on the call that taking production inhouse will help increase margins through scale efficiencies.

“We see a number of ways to improve margins by driving increased operating efficiencies, by increasing the capacity utilization in our facilities by bringing the production of Raxibacumab in-house.”